The Opportunity:

We are hiring a highly skilled and motivated Senior Scientist, Sample Management to join our Research & Clinical Bioanalytics (RCB) team at Bio21 Institute, in the heart of Melbourne's Biomedical Precinct. You will be a crucial role in ensuring compliance and efficiency in our sample management processes across all therapeutic areas and phases of development.

Reporting to the Manager of Compliance, you will:

• Lead and manage all sample and critical reagent activities within the RCB Bio21 department.
• Develop and implement effective sample management processes from bioanalytical laboratories to long-term storage.
• Ensure compliance with study protocols, informed consent forms, and regulatory frameworks.
• Collaborate with global RCB sites to align sample management processes.
• Act as the key contact for Clinical Development Operations to ensure effective sample management throughout the lifecycle.
• Oversee clinical samples at external bioanalytical laboratories.
• Develop sample management plans and coordinate sample shipments.
• Track and manage samples in long-term storage, ensuring compliance and proper handling.
• Manage contracts and budgets for long-term storage at external vendors.
• Participate in the Global Bioassays Management Committee (GBMC) and ensure compliance with accreditation/regulatory standards.

• Tertiary qualification in a scientific/medical/(bio)pharmaceutical discipline.
• Post-graduate qualification (Masters minimum) with at least 6 years of experience in pre-clinical and clinical development of biopharmaceuticals.
• Expert knowledge in compliant clinical sample management within a bioanalytical laboratory environment.
• Proficiency in Microsoft Office and laboratory management software (e.g., LIMS).
• Strong leadership skills and the ability to inspire and mentor a team.
• Broad perspective of the biopharmaceutical development process.

• Competitive salary and benefits package.
• Opportunities for professional development and career growth.
• Collaborative and supportive work environment.
• Access to state-of-the-art facilities and resources.